US biotechnology company Novavax Inc (Nasdaq: NVAX) announced on Wednesday that it has received Marketing Authorisation from the European Commission for its updated 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union.

This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).

The authorisation was based on non-clinical data that indicated the company's updated vaccine offers cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1. In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

Novavax's updated Nuvaxovid vaccine is also authorised for use in the United States and is in line with guidance from the US Food and Drug Administration (FDA), EMA and the World Health Organisation to target the JN.1 lineage this autumn.